UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Previous Pancreatitis and Prolonged Procedure Time in the risk of post-ERCP pancreatitis
Title of the study (Brief title)	Previous pancreatitis and time of ERCP in PEP
Region	Japan

Condition
Condition	post ERCP pancreatitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Basic objectives2	Others
Basic objectives -Others	the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the relationship between previous history of pancreatitis and time for cannulation or total procedure time in the risk of PEP
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	more than 20 years old
Key exclusion criteria	None
Target sample size	1335

Research contact person
Name of lead principal investigator	Atsuhiro Masuda
Organization	Kobe University Hospital
Division name	Dep. of Gastroenterology
Address	7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	Atsuhiro Masuda
Organization	Kobe University Hospital
Division name	Dep. of Gastroenterology
Address	7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-6305
Homepage URL
Email	atmasuda@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	retrospective study The clinical data of consecutive 1,335 ERCP practices performed at Kobe University Hospital from April 2006 to June 2010 were collected. In this study, the risk factors of PEP are defined as follows considering the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines: female gender, difficulty with cannulation (requiring less than 15 minutes, more than 15 minutes), total procedure time (requiring less than 30 minutes, more than 30 minutes), pancreatic duct injection, pancreatic IDUS, pancreatic juice cytodiagnosis, pancreatic duct brush cytodiagnosis, pre-cut sphincterotomy, previous pancreatitis, and suspected SOD.

Management information
Registered date	2015 Year 09 Month 28 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022128